Label: GUNA THROAT AND GUMS- achillea millefolium - aconitum napellus - arnica montana - atropa belladonna - calcium sulfide - comfrey root - echinacea angustifolia - echinacea purpurea - hypericum perforatum - witch hazel - spray
- NDC Code(s): 17089-479-27
- Packager: Guna spa
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 17, 2021
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- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- QUESTIONS
- DIRECTIONS
- WARNINGS
- PREGNANCY
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WARNINGS
- Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a health professional promptly. ●Stop use and ask doctor if symptoms persist more than 3 days. ● If pregnant or breast-feeding ask a health care professional before use.● Keep out of reach of children. In case of overdose, get medical seek professional assistance or contact a Poison Control Center immediately. ● Contains ethyl alcohol 20%
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INGREDIENTS AND APPEARANCE
GUNA THROAT AND GUMS
achillea millefolium - aconitum napellus - arnica montana - atropa belladonna - calcium sulfide - comfrey root - echinacea angustifolia - echinacea purpurea - hypericum perforatum - witch hazel - sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-479 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] in 50 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 50 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 4 [hp_X] in 50 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 2 [hp_X] in 50 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 2 [hp_X] in 50 mL WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 2 [hp_X] in 50 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] in 50 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] in 50 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 3 [hp_X] in 50 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength ABIES SACHALINENSIS VAR. SACHALINENSIS OIL (UNII: 9H7TY1ZV7Q) ALCOHOL (UNII: 3K9958V90M) LEMON OIL (UNII: I9GRO824LL) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17089-479-27 1 in 1 BOX 02/17/2021 1 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/17/2021 Labeler - Guna spa (430538264) Establishment Name Address ID/FEI Business Operations Guna spa 338587646 manufacture(17089-479)
